Multiple SclerosisPhase 1MST3KNCT02760056
Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study
A Phase 1 study testing Liothyronine sodium in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3) in subjects with multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Liothyronine sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2016to 10 Jan 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of MS of any type
- Age 18 to 50 years
- Weight range 45-90 kg (100-200 lbs)
- Lesions on brain MRI
Who cannot join
- History of hypo or hyperthyroidism and a normal TSH
- History of high blood pressure (hypertension) [
- Resting blood pressure greater than 150/95, resting heart rate greater than 100
- History of coronary artery disease or clinically significant arrhythmia, clinically significant abnormalities on EKG
- History of diabetes
- History of anemia or renal (kidney) disease
Show all 24Show fewer
- Clinically significant abnormalities on metabolic panel or serum hematocrit below 32 %
- History of atrophic gastritis
- History of anxiety disorder or bipolar disorder
- Serious psychiatric or medical conditions that would preclude reliable participation in the study
- Use of illicit substances or alcohol abuse
- Current use of fingolimod (Gilenya)
- Current or prior use of mitoxantrone (Novantrone)
- Current use of stimulants (methylphenidate, atomoxetine, dextroamphetamine,phentermine)
- Current use of any blood thinners such as warfarin or apixaban (Aspirin is ok)
- Medications which would metabolized faster in the presence of thyroid hormone (Insulin, oral hypoglycemic agents and oral anticoagulants)
- Severe head tremors (which would impair the ability to perform VEPs)
- Present or recent use of medications that could interact with the thyroid hormone (iodine containing agents such as kelp supplements, amiodarone, iodinated contrast given for CT or xray), P450 stimulants (phenytoin, carbamazepine, phenobarbital, and rifampin)
- Corrected visual acuity worse than 20/50 in either eye or other eye issues that would prevent reading of a standard eye chart
- Head tremors or other tremors that would prevent sitting relatively still for a vision test
- Patients taking proton pump inhibitors (PPIs) or H2 blockers will be excluded unless they can safely not take these medications during the week of study drug administration.
- Patients taking Ampyra (dalfampridine) will be excluded unless they can safely not take these medications during the week of study drug administration.
- Pregnancy, breastfeeding, or intention to become pregnant in the following month
- Inability to receive an MRI (e.g. implanted metal device)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3) in subjects with multiple sclerosis
Read the detailed description
This is a pilot, phase I, placebo controlled clinical trial of short-term high-dose thyroid hormone to promote remyelination in MS. Permanent clinical disability in MS is likely caused by the neuronal damage and degeneration that follows recurrent demyelination with progressive failure of remyelination. Thyroid hormone (TH) is required for central nervous system (CNS) myelination during development, and CNS remyelination in animal models of MS, a process similar to developmental myelination, has also been found to be promoted by TH. This study will ascertain the safety, tolerability and maximum tolerated dose of TH in people with MS, explore reliability for a potential signal of treatment efficacy and mechanism, and optimize procedures for a full scale clinical trial to evaluate the efficacy of pulsed TH for promotion of remyelination in MS.
The safety and tolerability of this treatment will be assessed using subjects' self-report of symptoms, the validated Hyperthyroid Symptom Scale (HSS), and blood pressure measurements. a
- Conditions
- Multiple Sclerosis
- Being tested
- Liothyronine sodium, Placebo
- Keywords
- Thyroid hormone, Remyelination
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liothyronine sodiumDrug
Also called Cytomel
Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.
PlaceboDrug
Patient will receive a matching placebo to take twice daily for one week.
| Study group | Role | What they receive |
|---|---|---|
| Liothyronine (cytomel) | Active comparator | Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week Receives: Drug: Liothyronine sodium |
| Placebo | Placebo comparator | Subject will take matching placebo twice a day for one week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS
MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)
Measured: 1 week
Secondary outcomes (1)
Reliability of Visual Evoked Potential (VEP) Testing (ICC)
P100 latency will be compared before and after treatment with L-T3 in subjects receiving the active treatment to assess reliability of the test for future assessment of treatment effect.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start6 Jun 2016
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation with monitoring for safety and tolerability, as well as reliability of VEP testing.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Cameron, Oregon Health and Science University
- Investigators
- Michelle Cameron, MD, Principal investigator, OHSU Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760056
- Sponsor's protocol ID
- IRB 15101
- Acronym
- MST3K
- Status last verified
- May 2018
- First submitted
- 5 Apr 2016
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Wooliscroft L, Altowaijri G, Hildebrand A, Samuels M, Oken B, Bourdette D, Cameron M. Phase I randomized trial of liothyronine for remyelination in multiple sclerosis: A dose-ranging study with assessment of reliability of visual outcomes. Mult Scler Relat Disord. 2020 Jun;41:102015. doi: 10.1016/j.msard.2020.102015. Epub 2020 Feb 20.
PubMed 32120028
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study
- ClinicalTrials.gov ID
- NCT02760056
- Acronym / sponsor ID
- MST3K / IRB 15101
- Conditions
- Multiple Sclerosis
- Keywords
- Thyroid hormone, Remyelination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Posted 19 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3) in subjects with multiple sclerosis
Detailed description
This is a pilot, phase I, placebo controlled clinical trial of short-term high-dose thyroid hormone to promote remyelination in MS. Permanent clinical disability in MS is likely caused by the neuronal damage and degeneration that follows recurrent demyelination with progressive failure of remyelination. Thyroid hormone (TH) is required for central nervous system (CNS) myelination during development, and CNS remyelination in animal models of MS, a process similar to developmental myelination, has also been found to be promoted by TH. This study will ascertain the safety, tolerability and maximum tolerated dose of TH in people with MS, explore reliability for a potential signal of treatment efficacy and mechanism, and optimize procedures for a full scale clinical trial to evaluate the efficacy of pulsed TH for promotion of remyelination in MS.
The safety and tolerability of this treatment will be assessed using subjects' self-report of symptoms, the validated Hyperthyroid Symptom Scale (HSS), and blood pressure measurements. a
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dose escalation with monitoring for safety and tolerability, as well as reliability of VEP testing.
| Arm | Type | Receives |
|---|---|---|
| Liothyronine (cytomel) | Active comparator | Drug: Liothyronine sodiumSubjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week |
| Placebo | Placebo comparator | Drug: PlaceboSubject will take matching placebo twice a day for one week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of MS of any type
- Age 18 to 50 years
- Weight range 45-90 kg (100-200 lbs)
- Lesions on brain MRI
Key exclusion criteria (24 listed)
- History of hypo or hyperthyroidism and a normal TSH
- History of high blood pressure (hypertension) [
- Resting blood pressure greater than 150/95, resting heart rate greater than 100
- History of coronary artery disease or clinically significant arrhythmia, clinically significant abnormalities on EKG
- History of diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liothyronine sodiumAlso: CytomelSubjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week. | Drug | Liothyronine (cytomel) |
| PlaceboPatient will receive a matching placebo to take twice daily for one week. | Drug | Placebo |
Primary outcome
Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS
Time frame: 1 week
MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)
1 secondary outcome
Reliability of Visual Evoked Potential (VEP) Testing (ICC)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32120028Wooliscroft L, Altowaijri G, Hildebrand A, Samuels M, Oken B, Bourdette D, Cameron M. Phase I randomized trial of liothyronine for remyelination in multiple sclerosis: A dose-ranging study with assessment of reliability of visual outcomes. Mult Scler Relat Disord. 2020 Jun;41:102015. doi: 10.1016/j.msard.2020.102015. Epub 2020 Feb 20.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Cameron, MD principal investigator
OHSU Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liothyronine sodium in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.